NCT03642171

Brief Summary

The study is a long term Post Market Surveillance Study involving women who will received UT 380® device as a contraceptive method.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

July 26, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2024

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2024

Enrollment Period

5 years

First QC Date

July 16, 2018

Last Update Submit

March 18, 2025

Conditions

Contraceptive; Complications, Intrauterine

Keywords

ContraceptionIntrauterine DeviceUT380

Outcome Measures

Primary Outcomes (3)

  • Unintended pregnancy rate

    Unintended pregnancy rate

    5 years

  • Device expulsion rate

    Device expulsion rate

    5 years

  • Discontinuation rate

    Discontinuation rate

    5 years

Secondary Outcomes (14)

  • Extra uterine pregnancy rate

    5 years

  • Assessment of physicians satisfaction regarding the use of the UT380 using 5 points likert scale (1: not at all satisfied 5: very satisfied)

    5 years

  • Assessment of patients satisfaction regarding the use of the UT 380® using 5 points likert scale (1: not at all satisfied 5: very satisfied)

    5 years

  • Removal rate of the UT380® due to excessive bleeding

    5 years

  • Removal rate of the UT380® due to pain

    5 years

  • +9 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsUT380® is intended to be used in nulliparous, uniparous and multiparous women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patients will be recruited in France city privates practicing gynaecologist.

You may qualify if:

  • Woman \> 18 years old
  • nulliparous, uniparous and multiparous
  • not currently using a contraceptive method or are willing to switch to a new reversible contraceptive
  • with an indication of implantation of a UT380® IUD
  • agreeing to participate in the study

You may not qualify if:

  • Patient with risk of post implantation bleeding or high level of bleeding during menstruation period
  • Patient with a risk of infection
  • Patient that meet any of the absolute contraindication of UT 380®
  • Any other elements that the investigator may think relevant and cannot allow the use of UT380®

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quanta Medical

Boulogne-Billancourt, 92100, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2018

First Posted

August 22, 2018

Study Start

July 26, 2018

Primary Completion

July 26, 2023

Study Completion

September 23, 2024

Last Updated

March 21, 2025

Record last verified: 2024-03

Locations

FR(1)